Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery

Not Applicable

Completed

• Conditions: Gastric Bypass Surgery; Obesity
• Interventions: Other: Solid Meal; Other: Liquid Meal

• Registration Number: NCT01938469
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).

Detailed Description

The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.

Gastric emptying will be measured by the acetaminophen test.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Severely obese patients undergoing gastric bypass surgery (GBP)

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solid Meal	Solid Meal	Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).
Liquid Meal	Liquid Meal	Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Primary Outcome Measures

Name	Time	Method
Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.	1 month before GBP surgery, 12-15 months post surgery
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.	1 month before GBP Surgery, and 12-15 months post surgery
Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.	1 month before GBP surgery, and 12-15 months post surgery
Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.	1 month before GBP , 12-15 months post GBP
Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.	1 month before GBP, 12-15 months post GBP

Trial Locations

Locations (1)

St. Lukes- Roosevelt Hospital- New York Obesity Research Center; 🇺🇸 New York, New York, United States